The WorkingBuildings team kicked off the partnership with this client by visiting each compounding and infusion location and conducting a gap analysis to identify the current state and the steps needed to meet USP standards. Each cleanroom is subject to specific temperature, humidity, and HVAC standards as well as requirements for architectural details and finishes able to withstand frequent cleaning as outlined in the USP compounding standards. The team held weekly calls to evaluate the progress at each site.
Throughout the initial engagement covering more than a dozen clinical sites—and in dozens of projects since—members of the WorkingBuildings team leveraged their extensive clinical and regulatory experience and expertise in mechanical systems, architecture, and engineering controls
to help the facilities identify and close gaps necessary for compliance with the USP standards. The WorkingBuildings teams work alongside the architects and general contractors, supporting regulatory requirements in the design phase and ensuring that components have been installed
correctly and function as intended as part of construction quality control during the construction phase.
Along the way, WorkingBuildings not only identified potential issues but also recommended corrective actions. In some cases, for example with HVAC systems in existing facilities, the team identified when existing systems could be reused with minor upgrades, when systems needed to be enhanced, and when they needed to be replaced entirely. In other instances, the team leveraged its deep understanding of day-to-day cleanroom operations to improve the end user experience—including laying out process flow diagrams and reviewing drawings to weigh in on the location of work tables, sinks, pass-through windows, and primary engineering controls—at the beginning of the project, before construction began. Once a site was operational, WorkingBuildings supported the pharmacy team and other team members to maintain the space and ensure continued compliance with support in the required ongoing facility maintenance and environmental monitoring (EM) analysis.
As part of the ongoing partnership, WorkingBuildings continues to provide all the cleanroom locations with off-site monitoring; maintenance and emergency response planning; coordination of certification efforts; and addressing compliance issues if they arise.
